Various processes use fluid provided in flexible bio-process bags, e.g. a cellbag or other single-use bio reactor, a cell culture media bag or a single-use mixer bag. Before filling the flexible bio-process bag with fluid, the flexible bio-process bag is tested for leaks and optionally provided with a certificate. A flexible bio-process bag having a leak exceeding a certain diameter may be tested as unusable.
Conventional measurement systems for testing flexible bio-process bags typically inflates the flexible bio-process bag with a fluid, such as air, and fills it up to a reference pressure. The pressure of the flexible bio-process bag is then monitored over a predetermined time period. The flexible bio-process bag is then tested as unusable if the pressure after the predetermined time period has fallen below a test threshold and classified as usable if the monitored pressure is equal to or above the test threshold.
A drawback with such conventional systems is that the measurements are sensitive to air pressure variations in the surrounding environment, such as changing weather or opening or closing of doors or windows. A further drawback is that the tests are time consuming, especially when testing for small leaks. A further drawback is that the accuracy is low. Yet a further drawback is that only one flexible bio-process bag at a time can be tested. Yet a further drawback is that such tests are only valid for a particular flexible bio-process bag volume. Yet a further drawback is that such tests are sensitive to membrane creep.
Thus, there is a need for an improved measurement system and method thereof.